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The Cardo Medical Hip System components are for use in total hip arthroplasty as a result of:

• Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip
• Correction of functional deformity
• Avascular Necrosis
• Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur
• Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results
  These components are single use only and are intended for implantation without bone cement.

The previously cleared Cardo Medical Hip System consists of:

• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) femoral stems,
• cobalt chrome (CoCr) femoral heads
• commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) acetabular shells
• ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts and
• titanium alloy (Ti-6Al-4V) bone screws.
  The proposed devices are a line extension to the previously cleared system to add 36mm femoral heads and 36mm inserts.

The provided text describes a 510(k) premarket notification for a line extension of the Cardo Medical Hip System, specifically the addition of 36mm femoral heads and inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone clinical study with human subjects.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in the context of this 510(k) submission. The document focuses on demonstrating that the new components do not introduce new questions of safety or effectiveness compared to the existing, cleared device and its predicates.

Here's an analysis based on the information provided, highlighting why certain sections are N/A:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, the acceptance criteria for this 510(k) submission are implicitly met by demonstrating substantial equivalence to existing predicate devices. This means the new components must demonstrate similar technological characteristics and the same intended use as the predicates, and not raise new questions of safety or effectiveness.
• Reported Device Performance: The "performance" here refers to the new components being "equivalent" to the predicate devices in materials, design, packaging, and sterilization. No new performance data (e.g., in terms of clinical outcomes or diagnostic accuracy) compared to defined criteria is presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• N/A. This submission is not based on a clinical test set or data from human subjects but on demonstrating equivalence through technical characteristics (materials, design, etc.) and referencing existing biocompatibility and mechanical testing data for the "worst-case" predicates. No specific patient data or provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. This submission does not involve a test set requiring expert ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. Not applicable, as there is no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A. This device does not involve AI or human image interpretation; it is a physical medical implant. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. Not applicable, as this device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• N/A. Ground truth of this nature is not applicable to a 510(k) submission for a line extension of an orthopedic implant. The "truth" in this context is the regulatory determination of substantial equivalence based on engineering and materials data, and comparison to already cleared devices.

8. The sample size for the training set

• N/A. Not applicable. The device is a physical implant, not a software algorithm requiring a training set.

9. How the ground truth for the training set was established

• N/A. Not applicable, as there is no training set mentioned or implied for this device.

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When used with the Patello-femoral System: The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with: - Degenerative arthritis in the distal femur and patella; . - A history of patellar dislocation or fracture; . - Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists. When used with the Total Knee System: The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis; - Post-traumatic loss of knee joint confiquration and function: . - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability; - Revisions of previous unsuccessful knee replacement or other procedure. . Additional indications for posteriorly stabilized components: - Ligamentous instability requiring implant bearing surfaces with increased constraint: . - Absent or non-functioning posterior cruciate ligament. . The patella components are single use only and intended for implantation with bone cement.

The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPE with pegs on the non-articulating surface. The surgeon uses the components to resurface the patella during either a patella-femoral replacement or a total knee replacement. The device is designed for cemented fixation only.

The provided text describes a Premarket Notification Submission (510(k)) for the Cardo Medical Align 360® Medialized Patella Component. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity for diagnostic imaging devices).

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, design, and intended use, and by confirming that the device meets general guidance documents for knee implants. The "tests" mentioned are likely mechanical or biocompatibility tests, rather than clinical performance studies.

Therefore, the following information is derived from the context of a 510(k) submission for a medical implant, where "acceptance criteria" and "study" typically refer to adherence to established standards and comparison to predicate devices, rather than a clinical trial with performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The description mentions "tests were performed" and "testing has shown," which typically refers to mechanical and material testing rather than a patient-based test set or clinical trial. Hence, "sample size" in a clinical sense is not applicable here.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a medical device implant, the data would typically come from in-house mechanical testing or accredited laboratory testing on device prototypes/units. It would not typically involve patient data unless a clinical trial was specifically required, which is not indicated here for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission is for a medical implant and relies on mechanical and material testing, as well as comparison to predicate devices and adherence to regulatory guidance. It does not involve a diagnostic test where expert-established ground truth is required.

4. Adjudication method for the test set:

• Not applicable. This concept relates to studies where multiple readers or experts assess cases to establish a ground truth or resolve discrepancies. This submission pertains to device design, material, and mechanical performance, not diagnostic interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a medical implant (patella component for knee replacement), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. As mentioned, this device is a physical implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the equivalence claim, the "ground truth" is the performance and characteristics of the legally marketed predicate devices (Cardo Medical Dome Patella, Scorpio Knee System) and the requirements outlined in the FDA Guidance document. The device aims to demonstrate it is "substantially equivalent" to these established benchmarks.
• For the mechanical/material testing, the ground truth would be engineering specifications, material science standards, and performance metrics defined by relevant ISO standards or FDA guidance for knee implants.

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device implant and does not involve machine learning or AI, and thus no "training set" in that context.

9. How the ground truth for the training set was established:

• Not applicable. (See #8)

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The Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with:

• Degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• Trauma (including fractures) .
• Tumor ●
• Deformity (defined as kyphosis, lordosis or scollosis) .
• Pseudoarthrosis .
• Failed previous fusions. ●
  The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

The Cardo Medical Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine. The modified system includes the addition of a fixed angle cervical screw as an option for the surgeon.

The Cardo Medical Cervical Plate System is a medical device designed for anterior interbody fixation of the cervical spine. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on acceptance criteria with specific performance metrics.

Based on the provided text, here’s an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "the device must withstand X force for Y cycles"). Instead, it references a standard and states equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size (number of devices or tests performed) for the mechanical testing conducted according to ASTM F1717.
• Data Provenance: The study is a prospective engineering test conducted on the Cardo Medical Cervical Plate System components. The location of the testing is not specified, but it would presumably be in a laboratory setting. There is no mention of clinical data or patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This question is not applicable to this type of submission. The "ground truth" for mechanical testing is established by the specified standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes. The focus is on physical and mechanical properties.

4. Adjudication Method for the Test Set:

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies, typically involving multiple expert readers reviewing cases. For mechanical testing, the results are objectively measured against defined criteria within the standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• This question is not applicable. An MRMC study is relevant for evaluating diagnostic or screening devices where human readers interpret medical images or data, often with and without AI assistance. This submission is for a physical implant (cervical plate system), and its evaluation relies on mechanical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• This question is not applicable. This device is a physical implant, not an algorithm or AI-driven system. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

• The "ground truth" for this device's evaluation is primarily established by engineering standards and specifications, specifically ASTM F1717. This standard dictates the test methods for evaluating static and fatigue performance of spinal implant constructs. The results are compared against the performance of a predicate device that is already deemed safe and effective.

8. Sample Size for the Training Set:

• This question is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable for the same reasons as point 8.

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